Oral Osteoporosis Drugs (Bisphosphonates): Drug Safety Communication - Potential Increased Risk of Esophageal Cancer
July 22, 2011
FDA is reviewing published studies regarding oral bisphosphonate use causing increased rates of esophageal cancer. These studies have conflicting findings and FDA considers benefits of oral bisphosphonate drugs in preventing serious fracture in patients with osteoporosis outweigh the potential risks of treatment. Bisphosphonates available in the US include Fosamax (alendronate), Actonel (risedronate), Boniva (ibandronate), Atelvia (risedronate delayed release), Didronel (etidronate), and Skelid (tiludronate).
FDA reviewed information from four studies comparing the risk of esophageal cancer of bisphosphonate users to non users. The two largest studies using data from the United Kingdom’s General Practice Research Database (GPRD) had conflicting results, despite using the same database. One study found no increase in esophageal cancer risk. The other study found a doubled risk in patients who had taken bisphosphonates for 3 years or had 10 or more prescriptions for bisphosphonates. A third Danish study reported a reduced risk of esophageal cancer in patients taking oral bisphosphonates for a median of 1.5 years. A final study comparing alendronate (Fosamax) users with non-alendronate users found no greater incidence of esophageal cancer. The studies were observational and had a high risk for confounding and bias.
FDA’s safety review is ongoing. Patients concerned about this warning should discuss their current treatment plan with their prescriber or pharmacist.
Additional information is available at the following link:
- MedWatch Safety Alert:
July 22, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.